On November 26, 2025 Curasight A/S ("Curasight" or "the Company" (CPH: CURAS), a clinical stage radiopharmaceuticals company, reported its phase 1 trial investigating uTREAT in aggressive brain cancer is now open for patient enrollment.

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Regulatory approval from the Health Authority and ethical committee approval has been obtained, and all practical and logistical preparations at the trial site have been completed. Dosing the first patient is expected in the coming weeks.

The phase 1 trial is part of Curasight’s theranostic strategy developing more gentle and targeted diagnosis and treatment of certain types of cancer.

"It is a very exciting stage in the development of uTREAT, that we are now ready to enroll patients and progress the development of uTREAT as a potential more targeted therapeutic solution for patients with aggressive brain cancer. There is a high unmet medical need for new treatments for brain cancer, and we look forward to enrolling the first patient very soon," said Curasight’s CEO, Ulrich Krasilnikoff.

About the Phase 1 trial with uTREAT in brain cancer

The trial aims to investigate Curasight’s uTREAT as a new type of targeted radiopharmaceutical therapy in glioblastoma patients. Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from clinical studies with the ligand forming the backbone of uTRACE, demonstrating that almost all GBM patients (94%), express uPAR on the tumour.

About the uPAR theranostic platform

Curasight’s uPAR theranostic platform combines two key technologies – uTRACE and uTREAT both targeting the uPAR receptor. uTRACE is designed to deliver sensitive imaging for diagnosis, while uTREAT offers a targeted radiopharmaceutical solution. Together, they form an integrated approach to improving the diagnosis and treatment of cancers that express uPAR. Curasight’s ambition is to develop both uTRACE and uTREAT to improve diagnosis and treatment of uPAR-expressing cancers.

About high grade glioma

Treatment of glioblastoma and other high-grade gliomas (WHO grades 3 or 4) presents a significant unmet medical need, necessitating innovative and effective treatments. A total of approx. 65,000 patients are diagnosed with primary brain tumors and more than 30,000 patients are diagnosed annually with the most aggressive form, glioblastoma, in the US and EU. Approximately 10 % of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50% of the patients die within 14 months and after five years from diagnosis only 5% are still alive. External beam radiation is a cornerstone in the therapy of brain cancers. uTREAT could potentially replace or reduce the use of external beam radiation and thereby lower side effects to the healthy brain due to more specific tumor tissue targeting.

(Press release, Curasight, NOV 26, 2025, View Source [SID1234660982])

On November 26, 2025 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported that Dave Lennon, PhD, President and CEO, will participate in a fireside discussion at the Piper Sandler 37th Annual Healthcare Conference in New York City, NY on December 3, 2025, at 12:30 PM ET.

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A live webcast of the fireside chat can be accessed by visiting the Whitehawk Therapeutics IR website and will be available for replay for approximately 30 days following the event.

(Press release, Whitehawk Therapeutics, NOV 26, 2025, View Source [SID1234660981])

On November 26, 2025 SK Biopharmaceuticals, CO., Ltd., a biotech company specializing in research, development, and commercialization of treatments for central nervous system (CNS) disorders and oncology, reported a license agreement with the Wisconsin Alumni Research Foundation (WARF) to acquire the exclusive worldwide rights for research and development (R&D), manufacturing, and commercialization of WARF’s "WT-7695," a preclinical-stage radiopharmaceutical therapy candidate developed in collaboration with the University of Wisconsin-Madison.

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This agreement represents SK Biopharmaceuticals’ second in-licensed asset in the radiopharmaceutical therapy field, following its first asset "SKL35501 (formerly FL-091)" in 2024. Since then, SK Biopharmaceuticals has continued to strengthen its foundation in the radiopharmaceutical field through supply agreements with TerraPower, a U.S. nuclear innovation company, and PanTera, a Belgian radioisotope producer, securing Actinium-225 (225Ac), and through multiple research collaboration agreements to broaden its expertise and capabilities across the full radiopharmaceutical value chain.

WT-7695 is a small-molecule radiopharmaceutical candidate in preclinical stage designed to target carbonic anhydrase IX (CA9), a transmembrane protein that plays a critical role in cancer cell growth and metastasis under hypoxic conditions. CA9 is highly expressed in clear cell renal cell carcinoma (ccRCC)[1] and other solid tumors such as pancreatic and colorectal cancers — making it a validated and selective target for radiopharmaceutical therapy development. Preclinical studies have shown promising efficacy, suggesting that WT-7695 has the potential to become a best-in-class radiopharmaceutical candidate.

Through this license agreement, SK Biopharmaceuticals continues to pursue a balanced growth strategy, strengthening internal capabilities while expanding strategic partnerships to advance R&D in radiopharmaceutical therapy. The company aims to build a robust and comprehensive radiopharmaceutical value chain, encompassing drug discovery, radioisotope sourcing, preclinical and clinical development.

"This agreement underscores the promise of CA9 as a target in advancing cancer treatment for patients around the world," said Erik Iverson, CEO of WARF. "We’re deeply proud of the collaboration between our WARF Therapeutics team and the University of Wisconsin-Madison researchers, whose work paved the way for this partnership with SK Biopharmaceuticals. Together, we’re committed to accelerating the development of this promising therapy and bringing it closer to the patients who need it."

"By securing this promising candidate with demonstrated preclinical efficacy, SK Biopharmaceuticals will further diversify its radiopharmaceutical therapy portfolio and reinforce its R&D capabilities through global collaboration," said Donghoon Lee, CEO of SK Biopharmaceuticals. "We will continue to expand our pipeline based on validated targets, strengthen our expertise across the integrated radiopharmaceutical value chain, and accelerate the development of next-generation cancer treatments to deliver meaningful solutions for patients with high unmet medical needs worldwide."

(Press release, SK biopharmaceuticals, NOV 26, 2025, View Source [SID1234660980])

On November 26, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that its CEO, Motti Farbstein will present at NobleCon21—Noble Capital Markets’ Twenty First Annual Emerging Growth Equity Conference—at Florida Atlantic University, Executive Education Complex, in Boca Raton, Floria—on Wednesday, December 3rd, 2025 at 12:30 PM ET. Mr. Farbstein will also conduct 1×1 meetings with investors.

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Mr. Farbstein will present the latest developments in Can-Fite’s advanced stage drug development pipeline including the following trials:

Phase III liver cancer
Phase IIa pancreatic cancer
Phase III psoriasis
Phase IIb MASH
Upcoming Phase II in Lowe Syndrome
Can-Fite has numerous out-licensing and global distribution agreements in place worth up to $130 million for pharma indications, with an additional up to $325 million for veterinary indications.

A high-definition video webcast of the presentation will be available the following day on Can-Fite’s website www.canfite.com, and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website at www.nobleconference.com and on Channelchek www.channelchek.com, the investor portal created by Noble. The webcast will be archived on Can-Fite’s website, the NobleCon website, and on Channelchek.com for 90 days following the event.

(Press release, Can-Fite BioPharma, NOV 26, 2025, View Source [SID1234660979])

On November 26, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a New Drug Application (NDA) for sonrotoclax, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor.

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"Sonrotoclax is advancing with remarkable speed, from Breakthrough Therapy Designation to Priority Review, all within a short window," said Lai Wang, Ph.D., Global Head of R&D at BeOne. "That pace reflects both the strength of the data and the urgency of the need for patients with R/R MCL. With rapid, deep, and durable responses and a manageable safety profile, sonrotoclax is emerging as a potential best-in-class BCL2 inhibitor, alongside our two other transformative hematology assets – BTK inhibitor BRUKINSA, and investigational BTK degrader BGB-16673."

The NDA is supported by data from the global, multicenter, single-arm, open-label, Phase 1/2 study, BGB-11417-201 (NCT05471843), which enrolled 125 adult patients with R/R MCL who received prior treatment with a BTK inhibitor. Sonrotoclax achieved its primary endpoint of overall response rate (ORR) as assessed by an independent review committee (IRC), demonstrating clinically meaningful responses in this heavily pretreated population. The study also showed promising results across several secondary efficacy endpoints, including complete response (CR) rate, duration of response (DOR), and progression-free survival (PFS). The treatment was well-tolerated, and the risks were manageable.

BeOne will present the full results for the first time at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, December 6-9, in Orlando, Florida. (Oral Presentation: 663; December 7 from 5:00-5:15 PM EST).

Supporting efforts to rapidly advance global review and potential access, BeOne will participate in the FDA’s Project Orbis for sonrotoclax, an initiative that provides a framework for concurrent submission and review of oncology products among international partners. BeOne also intends to submit the Phase 1/2 data to other global regulatory bodies for the potential approval of sonrotoclax in R/R MCL, including the European Medicines Agency.

New drug applications for sonrotoclax for the treatment of R/R MCL and R/R chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) have also been accepted and are under review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for potential accelerated approval.

About Mantle Cell Lymphoma

Mantle cell lymphoma (MCL) is a rare subtype of aggressive non-Hodgkin lymphoma (NHL)1 that originates in B-cells located in the mantle zone of the lymph nodes. MCL accounts for approximately 5% of all NHL cases globally2, affecting an estimated 28,000 people3. MCL is often diagnosed at advanced stages4 and nearly all MCL patients will eventually develop refractory or relapsed (R/R) disease.5 The five-year survival rate for MCL is approximately 50%, reflecting the urgent need for new therapeutic options.6

About Sonrotoclax (BGB-11417)

Sonrotoclax is a next-generation and potentially best-in-class investigational B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Laboratory studies during early drug development have shown that sonrotoclax is a highly potent and specific BCL2 inhibitor with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies and is in development as a monotherapy and in combination with other therapeutics, including BRUKINSA. Notably, in early clinical trials, sonrotoclax plus BRUKINSA has demonstrated rapid and unprecedented rates of undetectable minimal residual disease (uMRD) in treatment-naïve patients with CLL. To date, more than 2,200 patients have been enrolled across the broad sonrotoclax global development program.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for sonrotoclax for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). In addition, the FDA has granted sonrotoclax Fast Track Designation for MCL and Waldenström macroglobulinemia, as well as Orphan Drug Designation for the treatment of adult patients with MCL, WM, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome.

(Press release, BeOne Medicines, NOV 26, 2025, View Source [SID1234660978])